BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    °M Warmer System

    Reg #: 3008773490 · FEI: 3008773490 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PAUL E. DANCHELL A/S
    Registration Number
    3008773490
    FEI Number
    3008773490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lyngvej 8
    City
    Jyderup Sjalland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K232107

    Owner / Operator

    Firm Name
    Paul E. Danchell A/S
    Operator Number
    10042718
    Address
    Lyngvej 8
    City
    Jyderup
    State
    DK-NOTA
    Postal Code
    4450
    Country
    DK
    Correspondent
    Claus Jensen

    US Agent

    Business Name
    Natus
    Contact Name
    Courtney Walton
    Address
    3610 County Road 101 S
    City
    Wayzata
    State
    MN
    ZIP
    55391
    Country
    US
    Email
    [email protected]
    Phone
    651 4215870

    Products

    Device Name Product Code
    Warmer, Thermal, Infusion Fluid LGZ
    Warmer, Blood, Non-Electromagnetic Radiation BSB

    Proprietary Names

    °M Warmer System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)